WRAPSODY® (REF WRAP-L09075)Recalls & reported problems
Merit Medical Systems, Inc. · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450845523), received between Apr 30, 2026 and Apr 30, 2026 — classified as 2 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Thrombosis/Thrombus2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
ON APRIL 7, 2026, INFORMATION WAS RECEIVED REGARDING A SUBJECT PARTICIPATING IN A CLINICAL TRIAL. THE SUBJECT EXPERIENCED GRADE 2 THROMBOSIS OF THE WRAPSODY STENT GRAFT REQUIRING MEDICAL INTERVENTION. DETAILS REGARDING THE SPECIFIC INTERVENTION AND PATIENT OUTCOME WERE NOT PROVIDED.
Patient problems: Thrombosis/Thrombus
MAUDE report 25048077 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
ON APRIL 15, 2026, INFORMATION WAS RECEIVED REGARDING A SUBJECT PARTICIPATING IN A CLINICAL TRIAL. THE SUBJECT EXPERIENCED THROMBOSIS OF THE WRAPSODY STENT GRAFT REQUIRING INTERVENTIONAL DECLOT PROCEDURES. ADDITIONAL DETAILS REGARDING INTERVENTION AND PATIENT OUTCOME WERE NOT PROVIDED.
Patient problems: Thrombosis/Thrombus
MAUDE report 25048004 ↗
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- COVERA AVSM09060Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall18 reports
- COVERA AVSM10080Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall16 reports
- COVERA AVSM10040Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall15 reports
- COVERA AVFM10060Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall14 reports
- COVERA AVSM09080Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall1 death14 reports
- COVERA AVSM10100Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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